"TUM's early experience with radiohybrid PSMA agents has allowed us to investigate the potential diagnostic performance of this new class of theranostic PSMA-targeting agents, which can be efficiently labeled with imaging radioisotopes such as 18F for PET imaging or with 177Lu for therapeutic use," said Matthias Eiber, attending physician, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "PSMA-targeted imaging agents labeled with 18F offer potential advantages that are important considerations in detecting and localizing prostate cancer - broad availability, based on the radioisotope's 110-minute half-life; consistent, centralized manufacturing with high batch production and high resolution PET scans."

Diagnostic efficacy of F-18-rhPSMA-7.3 PET Imaging for N-staging in Intermediate and High-Risk Prostate Cancer Patients Validated by Histopathology
The oral presentation detailed a 56-patient retrospective analysis investigating the efficacy of rhPSMA-7.3 (18F) PET/CT for primary lymph node staging in patients with intermediate and high-risk prostate cancer, spearheaded by Thomas Langbein, resident, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. Results from on-site reads were compared to morphological imaging and validated by histopathology. Patient-based analysis indicated that the sensitivity, specificity and diagnostic accuracy of rhPSMA-7.3 (18F) PET imaging were 81.3% (95% CI, 54.4–96.0%), 87.5 (95% CI, 73.2–95.8%) and 85.7% (95% CI, 73.8–93.6%), respectively. Those for morphological imaging were 33.3% (95% CI, 13.3–59.0%), 89.5% (95% CI, 75.2–97.1%) and 71.4% (95% CI, 57.8–82.7%), respectively. On template-based analysis, the sensitivity, specificity and accuracy of rhPSMA-7.3 (18F) PET were 63.6% (95% CI, 45.4-79.6%), 97.9% (95% CI, 95.5-99.2%) and 94.4% (95% CI, 91.2-96.6%), respectively, and those for morphological imaging were 15.2% (95% CI, 5.11-31.9%), 99.3%(95% CI, 97.5-99.9%) and 90.6% (95% CI, 86.9-93.6%), respectively. The mean PSA level of the patients in this primary prostate cancer study was 11.0 ng/mL.

About rhPSMA
rhPSMA-7.3 (18F) consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

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